Cephalic Version by Acupuncture-Moxibustion for Breech Presentation

Breech Presentation Clinical Trial

— ACUVERSE  

Official title:

A Simple Blind Controlled Randomized Trial: Cephalic Version by Acupuncture-moxibustion vs Placebo for Breech Presentation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487590
• Other study ID #: DGS 2006/0404
• Status: Completed
• Phase: N/A
• First received: December 5, 2011
• Last updated: January 16, 2012
• Start date: October 2006
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

For breech presentation, the cesarean section rate is decreased by external cephalic version. This is a painful operation, with some rare but serious complications. The aim of this trial is to evaluate the effectiveness of acupuncture-moxibustion, a non-invasive technique, to correct breech presentation before 37 weeks of gestation.

Description:

Monocentric controlled randomized trial in a simple blind fashion, comparing acupuncture-moxibustion versus a placebo in singleton pregnancies with breech presentation between 33+5 to 35+5 weeks of gestation. The intervention arm consists of acupuncture-moxibustion at the BL67 acupuncture point, for six seances of twenty minutes two days apart. In the placebo group, the cold light of an inactivated laser is to be applied in the same point during the same time. When cephalic version fail, a manual external cephalic version is to be proposed. The main outcome measure is cephalic presentation at 37+2 weeks of gestation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• breech presentation,

• SINGLETON

Exclusion Criteria:

• maternal age between 18 ans 45,

• multiple gestation,

• fetal or uterine malformation,

• premature rupture of membranes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Breech Presentation

Intervention

Other:
• Acupuncture moxibustion
Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart.
• Placebo
Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart

Locations

Country	Name	City	State
France	Hopital Jeanne de Flandre, CHRU de Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cephalic presentation	Each participant women will be examined at 37+2 weeks to determine the fetal presentation. Ultrasonography will be performed in case of doubt.	at 37+2 weeks of gestation	No
Secondary	Successful manual external cephalic version after intervention	In case of failure of acupuncture/moxibustion or placebo, the success of manual external cephalic version will be studied.	Before 41 weeks of gestation	No
Secondary	Cephalic presentation at delivery	The rate of cephalic presentation at delivery will be described	Date of delivery	No
Secondary	Cesarean section rate	The cesarean section rate will be described	Date of delivery	No
Secondary	Premature rupture of membranes	The rate of premature rupture of membranes will be described	Before delivery	Yes